1.1 Manufacturer Information Quidel Corporation Phone: 1.800.874.1517 Web: quidel.com 2005 East State Street, Suite 100 Fax: 1.740.592.9820 E-mail: qehs@quidel.com Athens, OH 45701 Emergency (24-Hour): 1.866.519.4752 1.2 Product Information Product Name: 10X PBS (Catalog #: 10-090100) Section 1 Product and Company Identification Intended Use: Components: General purpose laboratory reagent. 100 ml plastic bottle Section 2 Hazard Identification 2.1 Classification of the Substance of Mixture Not a hazardous substance or mixture. 2.2 GHS Label Elements, including Precautionary Statements Not a hazardous substance or mixture. 2.3 Hazards Not Otherwise Classified (HNOC) or not covered by GHS Section 3 Composition / Information on Ingredients 3.1 Mixtures - Contains non-hazardous quantities of proprietary ingredients according to OSHA (29 CFR 1910.1200). - Not a hazardous mixture according to Regulation (EC) No. 1272/2008. 3.2 No chemicals need to be disclosed according to the applicable regulations for the components in this kit. 3.3 This solution has been tested for sterility. Section 4 First Aid Measures 4.1 Description of First Aid Measures If inhaled: In case of skin contact: In case of eye contact: If swallowed: Move the person to fresh air and support breathing as required. Wash affected area with soap and water. Seek medical advice if irritation develops. Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists get medical attention. Never give anything by mouth to an unconscious person. Rinse mouth with water. Seek medical advice if irritation develops. 4.2 Most Important Symptoms and Effects (both acute and delayed) To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated. 4.3 Indication of Any Immediate Medical Attention and Special Treatment Needed No specific measures identified. Section 5 Fire Fighting Measures Only individuals properly trained and issued appropriate personal protective equipment should respond and attempt to extinguish a fire. 5.1 Suitable Extinguishing Media Page 1 of 5
For small fires, use dry chemical, carbon dioxide or alcohol-resistant foam. Section 5 Fire Fighting Measures (cont d) 5.2 Special Hazards Arising From the Substance or Mixture Nature of decomposition products not known. 5.3 General Fire Hazards The components within this kit will not significantly contribute to the intensity of a fire. 5.4 Fire Fighting Equipment Firefighters should wear full protective gear when responding to fires. Section 6 Accidental Release Measures Only individuals properly trained and issued appropriate personal protective equipment should respond and attempt to clean up a spill or release. A large spill of the components contained within this kit is unlikely. 6.1 Personal Precautions Avoid breathing vapors, mist or gas. 6.2 Environmental Precautions Contain spill to prevent migration to drains, sewers or open water sources. Discharge to the environment must be avoided. 6.3 Methods and Materials for Clean-Up Soak up with inert absorbent material (e.g., paper towel, etc.). Thoroughly wash the area with soap and water after a spill or release clean-up. 6.4 Recovery and Neutralization Collect spilled material and clean-up supplies and place in a sealed container for disposal. Refer to Section 13 for disposal guidance. Section 7 Handling and Storage 7.1 Specific Use For professional use only Not for use by the general public. 7.2 Precautions for Safe Handling As with all chemical and biological substances, avoid getting the components within this kit ON YOU or IN YOU. Wash exposed areas thoroughly after using this kit. Do not eat or drink while using this kit. This kit should be handled only by qualified clinical or laboratory employees trained on the use of this kit and who are familiar with the potential hazards. Universal Precautions should be followed when handling and working with this kit. Keep out of reach of the general public. 7.3 Conditions for Safe Storage (including any incompatibilities) To maintain efficacy, store according to the package insert instructions. 7.4 Incompatibilities To maintain efficacy, store according to the package insert instructions. Section 8 Exposure Controls and Personal Protection 8.1 Exposure Limits for the components within this kit. 8.2 Exposure Controls Engineering Measures Personal Protective Equipment Respiratory Protection Skin Protection Eye Protection Body Protection Hygiene Measures Use with adequate ventilation. needed under normal conditions of use. Handle with appropriately rated chemical resistant gloves. Gloves should be inspected prior to use. Use proper glove technique to remove gloves to avoid contact with skin. Wash hands after handling the components within this kit. Wear safety glasses with side shields or goggles to prevent eye contact. Use body protection appropriate for the task. A laboratory coat is recommended. Wash hands before use, after use and at the end of the workday. Page 2 of 5
Section 8 Exposure Controls and Personal Protection (cont d) 8.3 Environmental Exposure Controls No special environmental controls are required. 8.4 Special Notes. Section 9 Physical and Chemical Properties Characteristic Boiling Point ( C) Melting Point ( C) Specific Gravity (H20 = 1) Vapor Pressure (mm Hg) Vapor Density (Air = 1) Evaporation Rate (Ether = 1) ph Solubility in Water Appearance and Odor 10X PBS Soluble Colorless, odorless liquid Section 10 Stability and Reactivity Characteristic Component Stability Hazard Reaction Potential Conditions to Avoid Materials to Avoid Hazardous Decomposition Products 10X PBS Stable 11.1 Information on Toxicological Effects Acute Toxicity Skin Corrosion / Irritation Respiratory or Skin Sensitization Generative Cell Mutagenicity Carcinogenicity Section 11 Toxicological Properties No component of this kit present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by the ACGIH, IARC, NTP or OSHA. Reproductive Toxicity Teratogenicity Specified Target Organ Toxicity Single Exposure: Repeated Exposure: Page 3 of 5
Aspiration Hazard Section 11 Toxicological Properties (cont d) Potential Health Effects Inhalation: May cause respiratory tract irritation. Skin: May cause skin irritation upon contact. Ingestion: May be harmful if swallowed. Eyes: May cause eye irritation. 11.2 Signs and Symptoms of Exposure To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated for the components within this kit. 11.3 Additional Information Section 12 Ecological Information 12.1 Toxicity 12.2 Persistence and Degradability 12.3 Bioaccumulative Potential 12.4 Mobility in Soil 12.5 PBT and vpvb Assessment 12.6 Other Adverse Effects An environmental hazard cannot be excluded in the event of unprofessional handling or disposal. Section 13 Disposal Considerations 13.1 Waste Disposal Instructions Utilize appropriate personal protective equipment and spill control when handling wastes generated from using this kit. Do not discharge any of the solutions, reagents or controls into drains, water courses or onto the ground. 13.2 Disposal of Product and Contaminated Packaging Dispose of waste materials, unused components and contaminated packaging in compliance with country, federal, state and local regulations. If unsure of the applicable regulatory requirements, contact a licensed professional waste disposal service to dispose of this material. Section 14 Transportation Information 14.1 U.S Department of Transportation (DOT) This material is not regulated for transport. 14.2 International Air Transportation Association (IATA) This material is not regulated for transport. 14.3 International Maritime Dangerous Goods (IMDG) This material is not regulated for transport. 15.1 U.S. Federal Regulations OSHA Hazards SARA 302 The following chemicals are subject to reporting levels established by Sara Title III, Section 302: SARA 313 The following chemicals are subject to reporting levels established by SARA Title III, Section 313: SARA311/312 Hazards Section 15 Regulatory Information Page 4 of 5
15.2 State Regulations The following chemicals appear on one or more of the following state hazardous substance lists: Chemical Name CAS # CA MA MN NJ PA RI -- -- -- -- -- -- -- -- California Prop 65: 15.3 Canadian WHMIS Ingredient Disclosure List This kit does not contain any chemicals known to the State of California to cause cancer, birth defects, or any other reproductive harm. Chemical Name CAS # Minimum Concentration -- -- -- 15.4 Additional Regulatory Information Safety, Health and Environmental Regulations/Legislation Specific for the Mixture Chemical Safety Assessment Not completed for the components contained within this kit. HMIS Kit Classification: NFPA Kit Classification: Health Hazard: 0 Health Hazard (blue): 0 Chronic Health Hazard: * Fire Hazard (red): 0 Flammability: 0 Reactivity (yellow): 0 Physical Hazard: 0 Special Hazards (white): *Use additional care when handling this kit. Section 15 Regulatory Information (cont d) Section 16 Other Information Every effort has been made to adhere to the hazard criteria and content requirements of the U.S. OSHA Hazard Communication Standard, European Communities Safety Data Sheets Directive, Canadian Controlled Products Regulations, UK Chemical Hazard information and Packaging Regulations, and UN Globally Harmonized System of Classification and Labeling of Chemicals. PREPARED BY: Quidel Corporation SUPERSEDES: SDS-903en (v2010apr21) 12544 High Bluff Drive, Suite 200 San Diego, CA 92130 REVISIONS: General format revision. The information above is provided in good faith. It is believed to be accurate and represents the best information currently available to us. However, we make no warranty of merchantability, fitness for a particular purpose or of any other type, expressed or implied, with respect to products described or data or information provided, and we assume no liability resulting from the use of such products, data or information. Users should make their own investigations to determine the suitability of the information for their particular purposes, and the user assumes all risk arising from their use of the material. The user is required to comply with all laws and regulations relating to the purchase, use, storage and disposal of the material, and must be familiar with and follow generally accepted safe handling procedures. In no event shall Quidel be liable for any claims, losses, or damages of any individual or for lost profits or any special, indirect, incidental, consequential or exemplary damages of any kind, howsoever arising, even if Quidel has been advised of the possibility of such damages. SD9030000EN00 (08/16) Page 5 of 5